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8-K - CURRENT REPORT - ENDRA Life Sciences Inc. | ndra_8k.htm |
Exhibit 99.1
ENDRA Life Sciences Reports First Quarter 2021 Financial Results
and Provides Business Update
Conference call begins at 4:30 p.m. Eastern time today
ANN ARBOR, Mich. (May 17, 2021) – ENDRA Life Sciences
Inc. (“ENDRA”)
(NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound
(TAEUS®),
today reported financial results for the three months ended March
31, 2021 and provided a business update. Highlights of the first
quarter of 2021 and recent weeks include the
following:
●
Began screening patients for real-world
clinical validation of TAEUS at Rocky Vista University College of Osteopathic
Medicine. All clinical evaluation sites will compare the
liver fat measurements of the TAEUS system to the gold standard
MRI-PDFF.
●
Partnered with Hepion
Pharmaceuticals, a clinical-stage company focused on AI-driven
therapeutic drug development for the treatment of nonalcoholic
steatohepatitis (“NASH”) and liver disease.
ENDRA
signed a collaboration agreement with Hepion to incorporate TAEUS
as an add-on technology to support Hepion's patient screening and
biomarker measurement during its upcoming Phase 2b study of
CRV431.
●
Secured a new clinical study partnership with
Inselspital University Hospital in Bern, Switzerland. This
is the third clinical research partnership for ENDRA in Europe and
the sixth globally. Data from the Inselspital Bern study, along
with other ongoing or to-be-initiated studies, will be used to
bolster clinical evidence and further establish the clinical
utility of the TAEUS device for assessing non-alcoholic fatty liver
disease (“NAFLD”).
●
Added two sales representatives
to the commercial team in
Europe in anticipation of COVID-19-related restrictions
being lifted, bringing the ENDRA EU team to four.
●
Strengthened balance sheet via exercise
of warrants and proceeds from existing ATM facility. Cash and cash
equivalents as of March 31, 2021 were $16.8 million.
●
Strengthened TAEUS intellectual
property protection with issuance of additional U.S. patents.
Since the beginning of the year, four
U.S. patents have been issued to further protect the
Company’s proprietary TAEUS technology. ENDRA’s intellectual property portfolio
continues to grow and currently stands at 85 global assets, defined as patents issued, filed,
licensed or in preparation.
"We continue to advance commercialization
initiatives by driving awareness of our TAEUS system and expanding
our European sales team. In
April, ENDRA presented at the American Institute of
Ultrasound in Medicine’s Annual Integrative Ultrasound
Meeting, highlighting the features and
benefits of the TAEUS system. We have several more industry conferences planned through the balance
of the year to exhibit TAEUS and expand our database of potential
customers.” stated Francois Michelon, Chairman and Chief
Executive Officer of ENDRA. “As we await a decision from the
U.S. FDA regarding our 510(k) application, we remain confident in
our submission and look forward to a favorable outcome. In the
interim, and unrelated to our application, we continue to support our domestic
clinical evaluation partners to assess and monitor chronic liver
conditions.”
Renaud Maloberti, Chief Commercial Officer, commented, "Although
the environment continues to be challenging in many European
countries as COVID-19 vaccines have not been administered as
quickly as in the U.S., our growing commercial team is
cultivating existing
clinician contacts and positioned to
develop new ones to establish a strong foundation of leads when
in-person meetings and product demonstrations resume. In addition,
this commercialization effort includes working closely with our
partner, GE Healthcare, to leverage their extensive base of
ultrasound customers. The teams’ initial focus is to increase
local interest for ENDRA’s technology among radiologists
while also targeting clinicians in hepatology, endocrinology and
primary care which represent a significant market opportunity for
TAEUS.”
First Quarter 2021 Financial Results
●
Operating expenses decreased to $2.6 million in the first quarter of 2021 from
$3.1 million in the same period
in 2020. The decrease was
primarily due to reduced spending for outsourced product
development and investor relations and legal fees.
●
Net loss in the first quarter of 2021 was
$2.3 million, or $0.06
per share, compared with a net loss of
$3.3 million, or $0.29
per share, in the first quarter of
2020.
●
Cash and cash equivalents were $16.8
million as of March 31,
2021.
●
In the first quarter of 2021, ENDRA received
exercise notices for 3.6 million warrants resulting in additional cash
proceeds of $2.8 million, and
sold approximately 3.9 million
shares through its ATM facility for gross proceeds of $9.8
million.
●
The Paycheck
Protection Program loan in the amount of $308,600 received during
2020 has been forgiven in full by the Small Business Administration
and was treated as ‘Other Income’ per GAAP
regulations.
Conference Call and Webcast
Management will host a conference call and webcast today at 4:30
p.m. Eastern time to discuss these results, provide an update on
recent corporate developments and answer questions.
Dial-in Numbers
U.S./Canada: 888-506-0062
International: 973-528-0011
Replay Dial-in Numbers
U.S./Canada: 877-481-4010
International: 919-882-2331
Replay Passcode: 40908
The telephone replay will be available through 4:30 p.m. Eastern
time on May 24, 2021
Webcast
A live audio webcast will be available through the
Events
& Presentations page of the
Investors section of the company's website
at www.endrainc.com
A replay of the webcast will be available on the website for 60
days
About ENDRA Life Sciences Inc.
ENDRA Life Sciences Inc. is the pioneer of Thermo Acoustic Enhanced
UltraSound (TAEUS®),
a ground-breaking technology that mirrors some applications similar
to MRI, but at 50x lower cost and at the point of patient care.
TAEUS®
is designed to work in concert with
one million ultrasound systems in global use today.
TAEUS®
is initially focused on the
measurement of fat in the liver, as a means to assess and monitor
NAFLD and NASH, chronic liver conditions that affect over 1 billion
people globally, and for which there are no practical diagnostic
tools. Beyond the liver, ENDRA is exploring several other clinical
applications of TAEUS®,
including visualization of tissue temperature during energy-based
surgical procedures.www.endrainc.com.
Forward-Looking Statements
All statements in this release that are not based on historical
fact are "forward-looking statements" within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Forward-looking statements, which are based
on certain assumptions and describe our future plans, strategies
and expectations, can generally be identified by the use of
forward-looking terms such as "believe," "expect," "may," "will,"
"should," "could," "seek," "intend," "plan," "goal," "estimate,"
"anticipate" or other comparable terms. Examples of forward-looking
statements include, among others, estimates of the timing of future
events and achievements, such as the expectations regarding
milestones and future sales, our 510(k) submission with the FDA and
commercializing the TAEUS®
device; and expectations concerning
ENDRA's business strategy. Forward-looking statements involve
inherent risks and uncertainties which could cause actual results
to differ materially from those in the forward-looking statements,
as a result of various factors including, among others, our ability
to develop a commercially feasible technology; receipt of necessary
regulatory approvals; the impact of COVID-19 on our business plans;
our ability to find and maintain development partners, market
acceptance of our technology, the amount and nature of competition
in our industry; our ability to protect our intellectual property;
and the other risks and uncertainties described in ENDRA's filings
with the Securities and Exchange Commission. The forward-looking
statements made in this release speak only as of the date of this
release, and ENDRA assumes no obligation to update any such
forward-looking statements to reflect actual results or changes in
expectations, except as otherwise required by
law.
Company Contact:
David Wells
Chief Financial Officer
(734) 997-0464
investors@endrainc.com
www.endrainc.com
Investor Relations Contact:
Yvonne Briggs
LHA Investor Relations
(310) 691-7100
ybriggs@lhai.com
ENDRA Life Sciences Inc.
Condensed Consolidated Balance Sheets
|
March
31,
|
December
31,
|
Assets
|
2021
|
2020
|
Current
Assets
|
(Unaudited)
|
|
Cash
|
$16,842,753
|
$7,227,316
|
Prepaid
expenses
|
776,092
|
390,800
|
Inventory
|
726,608
|
589,620
|
Other current
assets
|
5,986
|
5,986
|
Total Current
Assets
|
18,351,439
|
8,213,722
|
Non-Current
Assets
|
|
|
Fixed assets,
net
|
225,817
|
212,242
|
Right of use
assets
|
321,563
|
339,012
|
Total
Assets
|
$18,898,819
|
$8,764,976
|
|
|
|
Liabilities
and Stockholders’ Equity
|
|
|
Current
Liabilities
|
|
|
Accounts payable
and accrued liabilities
|
$686,650
|
$910,183
|
Lease liabilities,
current portion
|
79,175
|
76,480
|
Total Current
Liabilities
|
765,825
|
986,663
|
|
|
|
Long
Term Debt
|
|
|
Loans
|
28,484
|
337,084
|
Lease
liabilities
|
252,345
|
271,908
|
Total Long Term
Debt
|
280,829
|
608,992
|
|
|
|
Total
Liabilities
|
1,046,654
|
1,595,655
|
|
|
|
Stockholders’
Equity
|
|
|
Series A
Convertible Preferred Stock, $0.0001 par value; 10,000 shares
authorized; 141.397 and 196.794 shares issued and outstanding,
respectively
|
1
|
1
|
Series B
Convertible Preferred Stock, $0.0001 par value; 1,000 shares
authorized; no shares issued and outstanding
|
-
|
-
|
Common stock,
$0.0001 par value; 80,000,000 shares authorized; 41,614,653 and
34,049,704 shares issued and outstanding, respectively
|
4,161
|
3,404
|
Additional paid in
capital
|
77,460,997
|
64,493,611
|
Stock
payable
|
115,842
|
10,794
|
Accumulated
deficit
|
(59,728,836)
|
(57,338,489)
|
Total
Stockholders’ Equity
|
17,852,165
|
7,169,321
|
Total
Liabilities and Stockholders’ Equity
|
$18,898,819
|
$8,764,976
|
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
|
Three Months
Ended
|
Three Months
Ended
|
|
March 31,
|
March 31,
|
|
2021
|
2020
|
Operating
Expenses
|
|
|
Research and
development
|
$1,141,486
|
$1,518,146
|
Sales and
marketing
|
160,935
|
114,955
|
General and
administrative
|
1,273,418
|
1,467,745
|
Total operating
expenses
|
2,575,839
|
3,100,846
|
|
|
|
Operating
loss
|
(2,575,839)
|
(3,100,846)
|
|
|
|
Other
Expenses
|
|
|
Amortization of
debt discount
|
-
|
(228,568)
|
Gain on
extinguishment of debt
|
308,600
|
-
|
Other income
(expense)
|
(2,037)
|
6,617
|
Total other
expenses
|
306,563
|
(221,951)
|
|
|
|
Loss from
operations before income taxes
|
(2,269,276)
|
(3,322,797)
|
|
|
|
Provision for
income taxes
|
-
|
-
|
|
|
|
Net
Loss
|
$(2,269,276)
|
$(3,322,797)
|
|
|
|
Deemed
dividend
|
(121,071)
|
-
|
|
|
|
Net loss
attributable to common stockholders
|
$(2,390,347)
|
$(3,322,797)
|
|
|
|
Net
loss per share – basic and diluted
|
$(0.06)
|
$(0.29)
|
|
|
|
Weighted
average common shares – basic and diluted
|
37,772,515
|
11,508,843
|
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
Three Months
Ended
|
Three Months
Ended
|
|
March
31,
|
March
31,
|
|
2021
|
2020
|
Cash
Flows from Operating Activities
|
|
|
Net
loss
|
$(2,269,276)
|
$(3,322,797)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
Depreciation and
amortization
|
31,425
|
21,586
|
Common stock,
options and warrants issued for services
|
321,949
|
511,080
|
Amortization of
debt discount
|
-
|
228,568
|
Amortization of
right of use assets
|
17,449
|
15,915
|
Stock payable for
investor relations
|
46,250
|
40,000
|
Gain on
extinguishment of debt
|
(308,600)
|
-
|
Changes in
operating assets and liabilities:
|
|
|
Increase in prepaid
expenses
|
(385,292)
|
(256,505)
|
Increase in
inventory
|
(136,988)
|
(61,493)
|
Decrease in other
current asset
|
-
|
8,750
|
Decrease in
accounts payable and accrued liabilities
|
(223,532)
|
(258,878)
|
Decrease in lease
liability
|
(16,868)
|
(14,593)
|
Net cash used in
operating activities
|
(2,923,483)
|
(3,088,367)
|
|
|
|
Cash
Flows from Investing Activities
|
|
|
Purchases of fixed
assets
|
(45,000)
|
(22,350)
|
Net cash used in
investing activities
|
(45,000)
|
(22,350)
|
|
|
|
Cash
Flows from Financing Activities
|
|
|
Proceeds from
warrant exercises
|
2,785,627
|
39,238
|
Proceeds from
issuance of common stock
|
9,798,293
|
-
|
Net cash provided
by financing activities
|
12,583,920
|
39,238
|
|
|
|
Net increase
(decrease) in cash
|
9,615,437
|
(3,071,479)
|
|
|
|
Cash, beginning of
period
|
7,227,316
|
6,174,207
|
|
|
|
Cash,
end of period
|
$16,842,753
|
$3,102,728
|
|
|
|
Supplemental
disclosures of cash items
|
|
|
Interest
paid
|
$-
|
$1,920
|
Income tax
paid
|
$-
|
$-
|
|
|
|
Supplemental
disclosures of non-cash items
|
|
|
Conversion of
convertible notes and accrued interest
|
$-
|
$493,814
|
Deemed
dividend
|
$121,071
|
$-
|
Conversion of
Series A Convertible Preferred Stock
|
$(7)
|
$(452)
|
Conversion of
Series B Convertible Preferred Stock
|
$-
|
$(23)
|
Stock dividend
payable
|
$(22,337)
|
$34,066
|
Right of use
asset
|
$321,563
|
$389,004
|
Lease
liability
|
$331,520
|
$394,412
|
# # #